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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038938
Receipt No. R000044406
Scientific Title Development of a predictive strategy for the detection of the patients with high risk for delirium
Date of disclosure of the study information 2020/01/24
Last modified on 2021/01/22

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Basic information
Public title Development of a predictive strategy for the detection of the patients with high risk for delirium
Acronym Deep Study
Scientific Title Development of a predictive strategy for the detection of the patients with high risk for delirium
Scientific Title:Acronym Deep Study
Region
Japan

Condition
Condition Malignant tumors
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study designs to develop a predictive strategy for the detection of the patients with high risk for delirium by analyzing bloods obtained from the patients who are in palliative care wards at the stage before and after the delirium onset.
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of factors associated with delirium onset.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients in palliative care unit
2) Patients who are not delirium at the time of hospitalization
3) Patients who can obtain consent form
Key exclusion criteria 1) Patients who are at Delirium at the time of hospitalization
2) Patient judged by the attending physician to be inappropriate
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Sano
Middle name
Last name Fuminori
Organization Kawasaki Medical School
Division name Clinical Oncology
Zip code 701-0192
Address Matsushima 577, Kurashiki, Okayama
TEL 086-462-1111
Email s.fuminori@gmail.com

Public contact
Name of contact person
1st name Sano
Middle name
Last name Fuminori
Organization Kawasaki Medical School
Division name Clinical Oncology
Zip code 701-0192
Address Matsushima 577, Kurashiki, Okayama
TEL 086-462-1111
Homepage URL
Email s.fuminori@gmail.com

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kawasaki Medical School
Address 577 Matsushima, Kurashiki, Okayama
Tel 086-462-1111
Email kmsrec@med.kawasaki-m.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 12 Month 20 Day
Date of IRB
2020 Year 02 Month 03 Day
Anticipated trial start date
2020 Year 02 Month 03 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 12 Month 20 Day
Last modified on
2021 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044406

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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